Operations Manager Clinical Trials

Location:

Miami, FL

Job Type:

Temporary Contract (15 Weeks)

Schedule:

Monday – Friday | 8:30 AM – 5:00 PM

Pay:

$41.00 – $56.00 per hour

Job Summary

We are seeking an experienced Clinical Trials Operations Manager to support a leading clinical research program during a 15-week contract assignment. This role is responsible for overseeing the operational execution of clinical trials, ensuring compliance with regulatory requirements, optimizing research processes, and supporting cross-functional teams to deliver high-quality clinical research. The ideal candidate has strong leadership skills, experience managing clinical trial operations, and a thorough understanding of FDA regulations, Good Clinical Practice (GCP), and clinical research workflows.

Responsibilities

• Oversee the day-to-day operations of multiple clinical research studies.
• Lead and support clinical research staff, ensuring adherence to study protocols and timelines.
• Collaborate with investigators, research coordinators, regulatory teams, sponsors, and study monitors.
• Monitor study progress, enrollment, and operational performance to ensure milestones are met.
• Ensure compliance with FDA regulations, Good Clinical Practice (GCP), IRB requirements, and sponsor guidelines.
• Develop and implement operational processes to improve efficiency and quality.
• Oversee clinical trial budgets, resource allocation, and operational reporting.
• Prepare for sponsor visits, monitoring visits, audits, and regulatory inspections.
• Identify operational challenges and implement effective solutions.
• Maintain accurate documentation and ensure data integrity throughout the clinical trial lifecycle.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare Administration, Nursing, Public Health, or a related field required; Master's degree preferred.
• Minimum of 5 years of experience in clinical research operations or clinical trial management.
• Previous leadership or management experience within a clinical research environment.
• Strong knowledge of FDA regulations, ICH-GCP guidelines, IRB processes, and clinical trial operations.
• Experience working with Clinical Trial Management Systems (CTMS) and electronic research platforms.
• Excellent organizational, analytical, and project management skills.
• Strong communication and leadership abilities with the ability to manage multiple priorities in a fast-paced environment.

CAREERXCHANGE, INC is an EOE.

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Skills:

• Analysis Skills
• Biology
• Budget Management
• Clinical Information Systems
• Clinical Research
• Clinical Trial
• Clinical Trial Management
• Communication Skills
• Cross-Functional
• Data Quality
• Documentation
• FDA Requirements
• GCP (Good Clinical Practices)
• Healthcare Administration
• Healthcare Quality
• ICH Regulations
• IRB/IEC (Institutional Review Board/Independent Ethics Committee)
• Leadership
• Maintain Compliance
• Multitasking
• Nursing Administration
• Operational Improvement
• Operations Management
• Operations Planning
• Operations Processes
• Operations Research
• Organizational Skills
• Process Improvement
• Project/Program Management
• Public Health
• Quality Management
• Regulations
• Regulatory Compliance
• Regulatory Requirements
• Research Protocols
• Resource Management

CAREERXCHANGE, Inc.